A rapid and sensitive liquid chromatography–tandem mass spectrometric (LC–MS/MS) assay method has been
developed and fully validated for the quantitative determination of pitavastatin in human plasma. A pitavastatin
stable labeled isotope (pitavastatin d4) was used as an internal standard. Analyte and the internal standard were
extracted from human plasma via solid phase extraction technique. The chromatographic separation was achieved on
a C18 column by using a mixture of acetonitrile–0.1% formic acid (90:10, v/v) as the mobile phase at a flow rate of
0.85 mL/min. The calibration curve obtained was linear (r
2
0.99) over the concentration range of 0.05–160 ng/mL.
Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of
1.5 min for each sample made it possible to analyze more than 450 plasma samples per day. The proposed method
was found to be applicable to clinical studies.